New England Journal of Medicine Highlights the Dangerous Problems of Counterfeit Viagra

The following post appeared on the web blog Knock Off Report(http://knockoffreport.com/on February 25, 2009.

The world, including the US, is being flooded with counterfeit Viagra and other erectile dysfunction medications. A report in the Feb 12, 2009 issue of the New England Journal of Medicine highlights the dangerous problems.

The article reports on a total of 150 non-diabetic patients with severe hypoglycemia (low blood glucose) were admitted to the five public hospitals in Singapore. The admissions were between January 1 and May 26, 2008. All the patients were men except one, ages ranged from 19 to 97 years (median, 51). Seven patients remained comatose as a result of prolonged decrease glucose to the brain,and four subsequently died.

Several patients (45/150 or 30%) admitted to ingesting illegal sexual-enhancement drugs before the onset of hypoglycemia. Samples of the drugs obtained from these patients and from drugs seized in police raids were analyzed by means of high-performance liquid chromatography. It was found that many of the preparations were contaminated with Glyburide (a powerful medication used to treat diabetes).

So people thought they were taking Cialis or Viagra. What they were often taking were herbal preparations (e.g. Santi Bovine Penis ErectingCapsule) that contained small amounts of the active ingredient (Cialis or Viagra), but which also contained glyburide.

Since none of the men were diabetic, they experienced a severe drop in blood sugar (hypoglycemia). Seven men sustained serious brain damage due to low blood sugar, of which four ultimately died.

Harmful ingredients found in counterfeit medicines include boric acid, leaded road paint, floor polish, shoe polish to get the sheen on the tablet, talcum powder, cement powder, chalk and brick dust, nickel and arsenic. Any active drug ingredient is usually minimal or simply wrong – one supply batch of fake Viagra was in fact amphetamine and not Viagra (sildenafil).

Here are some signs (from eDrugStore) to help you identify illegal "generic Viagra" [Cialis or Levitra:

• The site sells "generic VIAGRA" or "generic sildenafil citrate" [Viagra does not have a generic form available.]

• The site claims to sell a cheaper form of VIAGRA

• The price is cheaper than VIAGRA, by as much as 70%

• The site claims the drug is made to World Health Organization (WHO) standards, which may be a lie. The WHO does not review or approve any medication

• The drug is sold as a pill, but looks different from VIAGRA's normal color, shape and imprinting

• Delivery times may be extended (4 -21 days) due to product being shipped into the United States from a foreign country

• Shipping is initiated using a foreign country postal service to minimize chances of detection and seizure when entering United States

Source
An Unusual Outbreak of Hypoglycemia; N Engl J Med 2009 360: 734-736; Kao, Shih Ling, Chan, Cheng Leng, (Pharm.), B.Sc., Tan, Belinda, (Pharm.), B.Sc., Lim, C.C. Tchoyoson, Dalan, Rinkoo, Gardner, Daphne, Pratt, Edward, Lee, Marilyn, Lee, Kok Onn

GOOD, BAD and UGLY

Charles R. Earl, M.A., ABD
CEO, Communication Connections

A recent article on this site described the attempts by the World Health Organization (WHO) to define “counterfeit” pharmaceuticals. The solution to this quandary seems rather obvious to me. Let’s start with the assumption that only flawed pharmas require definition. The “good’ ones are those that maintain compound and quality integrity and function as they were intended to do. The “bad,” on the other hand, are those that either fail to perform or cause harm because their compounds or quality were inadvertently compromised. Finally, the “ugly” are those counterfeits or adulterations that were intentionally created to cause harm to reap unwarranted profits.

So, the essence of the definitions goes to whether or not the faulty pharmaceutical was the result of intentional or unintentional action. These definitions follow the same distinctions as one would encounter when deciding between first degree murder or negligent homicide as descriptions of culpability. One is a result of malice and forethought while the other comes about because of a lack of diligence, human error or equipment malfunction. The definition of the product falls to the intention of the manufacturer or party who alters the product. Clearly, intention should be determined through the judicial process, and the appropriate remedies should be levied at sentencing.

The bottom line, however, is not the intention behind the flawed product, but rather, the detection and elimination of the “bad” and the “ugly” from the supply chain. Policing agencies and courts can deal with the apprehension and adjudication of the actors who traffic the “bad” and the “ugly.” The industry’s role is to insure that counterfeits and adulterated pharmaceuticals are detected and intercepted prior to their arriving near providers and patients. Bad and Ugly will always be around, but if members of the supply chain commit to protecting the Good from the debilitating effects of the Bad and Ugly, then the entire industry, throughout the supply chain, will prosper.

It has often been said that “the perfect shouldn’t be the enemy of the good.” That statement may have some valiance in politics, football and polka dancing, but it could be catastrophic in pharmaceuticals and health care. The good isn’t good enough. Mere perfection is the only standard.

Recent Adulteration of Heparin Drives Newly Proposed USP Standards

This month the U.S. Pharmacopeia (USP) proposed a second revision to their standards for the blood thinner, Heparin. This measure is to increase patient safety particularly because adulterated heparin resulted in the reported deaths of more than 200 patients worldwide in 2007 - 2008.

Most standards tests are generated to ensure manufacture quality and not equipped to look at unknown contaminants that may be added deliberately—as was the case with heparin. In the recent heparin recall the drug was adulterated with over-sulfated chondroitin sulfate and was not detected by current methods available then.

While we applaud the USP for answering this new threat to our citizen’s health, it does indicate that our pharmaceutical security measures need to be more proactive rather than reactive. Current science now offers methods to scan products to alert the user of unknown contaminants through the use of EDXRD technology. For more information on this revolutionary solution, visit: www.xstreamsystems.net.

To read more on the proposed USP revisions visit: http://www.usp.org/pdf/EN/aboutUSP/heparinStatement.pdf

For more information on specific changes to the monograph standards, visit www.usp.org or contact mediarelations@usp.org.

Vested Interests in Counterfeit Drugs

The following article by Bright Simmons appeared in Business Daily Africa and deals with the complicated politics of global anti-counterfeiting initiatives.

Apparently many countries are not convinced that a collaborative international initiative is advantageous for all in respect to global pharmaceutical supply chain security.

February 23, 2009:
Counterfeit drugs are flooding into Africa, where up to one in three medicines can be fake, causing widespread suffering and death.

The World Health Organisation wants an international agreement to tackle the threat but is being thwarted by members such as India and Brazil, more concerned with vested interests than African patients.

To fight counterfeits, the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) first needs to define them—but this new definition is opposed by an unholy coalition ranging from global anti-corporate activists to Indian and Brazilian pharmaceutical associations and heavily-lobbied governments.

They claim the definition would covertly introduce stricter patent protection and prevent generics manufacturers from exporting cheap drugs to Africa (generics are copies of drugs whose patents have expired, although some are in dispute). They accuse IMPACT of being a front for Western “Big Pharma.”

But IMPACT principally consists of and is led by national drug-regulatory authorities. Participation is open to every WHO member, so power lies mainly with developing countries that have negligible pharmaceutical sectors—and where counterfeit drugs are most common. A leading light in IMPACT has been Nigerian cabinet minister Dora Akunyili, the famous fighter against counterfeit drugs.

Moreover, there is no basis in the accusation that the new definition of “counterfeit” would stifle the trade of good quality generic medicines through tougher patent enforcement. The new definition states: “disputes concerning patents must not be confused with counterfeiting.”

This seems clear enough. If IMPACT threatens the global trade in quality generics, as its opponents claim, why do international generics associations support it?

In December the European Generic-medicines Association (EGA) welcomed the new definition, specifically because it “puts an end to any confusion with alleged patent infringement products which have nothing to do with counterfeiting.” The International Generic Pharmaceuticals Alliance was a founder of IMPACT.

Indeed its fundamental principles match those of reputable Indian organisations such as the Confederation of Indian Industry (CII): fakes and sub-standards have “tainted the image of many Indian brands,” it notes, “…placing patients’ health at risk.”

The Organisation for Economic Cooperation and Development (OECD) estimated last year that up to 75 per cent of the world’s counterfeit drugs come from India, most of which end up in Africa.

Strange alliance
But a strange alliance of anti-business activists and business associations purporting to represent India’s best interests has successfully lobbied the government to oppose IMPACT. The Indian Pharmaceutical Association says the counterfeit definition would harm the drug industry.

The SME Pharma Industries Confederation (SPIC), called “for safeguarding the export interests of the SME (small- and medium-sized enterprises) sector” by opposing it.

Indian delegates subsequently blocked IMPACT’s progress at the recent WHO Executive Board meeting and are threatening to prevent progress at May’s World Health Assembly (WHA): all the horse-trading will be done in coming months because WHA decisions are based on consensus.

But India’s own world-class and brand-conscious major producers stand to lose from India’s opposition to IMPACT. Fake versions of successful Indian generics have begun to flood the market, not least in India itself, losing them money, damaging their image and increasing disease.

Another fake argument is that “counterfeiting is an issue of trademark violation and has no bearing on public health,” to quote anti-patent campaigner KM Gopakumar of the Indian Centre for Trade and Development (CENTAD) think-tank.

IMPACT’s definition makes no specific mention of trademark violation but does of course outlaw “false representation” and “fake packaging”: if the packet is fake, do you really expect to find real medicine inside?Without trademark protection, manufacturers cannot protect against counterfeits.

Cheap drugs are a boon to health but they must be of a high standard, lest they do more harm than good. IMPACT cannot save Africa but nor does it set out to do so. It merely provides guidance to countries.

IMPACT’s definition can serve as a template for an African legislature tightening laws against counterfeiting--or improving trademark law to help genuine brands compete. African governments must not allow fake accusations to obstruct the campaign against fakes.

Simons is an executive of Ghana’s IMANI and is also involved in developing SMS verification for medicines.

Pfizer Pfakes: broken hearted old Men

Charles R. Earl, M.A., ABD CEO, Communication Connections

A recent news item on this web site chronicled the massive distribution of counterfeit Pfizer products in the Mid-East. Actually, the problem is a more global one. Fake pharmaceuticals do not respect boundaries or jurisdictions. Fake drugs and their purveyors do not respect people, either. They insidiously penetrate every market, every demographic, everywhere. Various articles and research papers have identified the real harm done to patients by the nefarious substitution or adulteration of pharmaceuticals.

There is another massive downside to the “faking” industry that is rarely discussed. As a person who has sailed past my sixtieth (60th) birthday in recent years, I play golf, enjoy social activities and have clients who are in their “golden years.” The nest is empty, and perhaps, retirement goals have been achieved. A lifetime of stress and hard work has taken its toll on the body and the mind. As the person begins his glide pattern in life, he discovers that he has heightened energy and new purposes in life. But alas, the body that has been broken and abused for many years will not cooperate. But wait! Viola’ (maybe I should say “Viva”). What once was but a distant dream has now become quite feasible.

The potential for rekindling the romantic lives of these aging warriors has filled them with hope and optimism. Their significant others, while perhaps skeptical in the beginning, may share in their mates’ revivals with gusto and gladness. Then Whammo! Nothing happens. The dreams of reinvigorated lives together become downcast and droopy. The hope for shared love does not spring. The promises of new beginnings fade into distant memories of days gone by.

There are a multitude of snide jokes about the users of Viagra. There is, however, a real cost when the product is counterfeit. It is more than some randy old guy trying to get his jollies at the local bowling alley or cocktail bar. Real people, real couples, real frustration and disappointment color the landscape of people who had hoped to recapture the spark. Maybe they will grasp the hope anyway despite the failure of the drug, but the detour and the delay are unnecessary and avoidable.

WHO Knows the Definition of a Counterfeit Medication?

By: Alan Clock, Senior Vice President, XStream Systems

Back in November 2008, I presented the question on this blog and on several professional networking sites; How Do You Classify Counterfeit Pharmaceuticals? In this blog, I related the conundrum that I have found in discussions both within our organization and I have had in speaking with experienced industry thought leaders; What is the definition of a counterfeit pharmaceutical?

Thanks to all who did respond to my open ended question, basically your input further demonstrated my point that the definition of counterfeit pharmaceuticals is not as easy as one might think and clearly those in the know have many different perspectives and views.

As many of those who are involved in defeating counterfeit medications know, it is very important for the industry, regulatory agencies and healthcare consumers to have a full understanding and scope of this insidious problem. Counterfeiting of medications as we know it today threatens to rob whole populations of their health and confidence in our system of providing safe and effective healthcare. Having a clear universal definition of the problem is a basic starting point for us to be effective in dealing with this global plague.

In my blog, I ultimately turned to the World Health Organization (WHO) for some clarity and found that their broad definition surprisingly very open ended as well.
Apparently the WHO has attempted in its most recent Executive Board Meeting in January to draft a more precise definition of “counterfeit” as it relates to medication and medical devices. They also attempted to properly delineate the organizations mandate to tackle the problem. Ultimately they, like the rest of us wound up stalled in their attempt.

It appears that they too realized the broad scope of the issue and recognized that it is difficult to do battle against a serious world health issue when one cannot properly identify and define the opponent.

According to published reports the WHO Executive Board disagreed over the refined definition and had to postpone their efforts until their May World Health Assembly in Geneva, Switzerland.

Here is hoping that this important organization comes to a consensus and gives us all some guidance as to a proper definition of scope of this very important problem. As of late, most within the pharmaceutical supply chain have relied on WHO statistics as a baseline for understanding the scope of counterfeit medications. The WHO is acknowledged as the standard of global guidance and their efforts are important in defeating this threat to healthcare worldwide.

WHAT SHOULD PFIZER DO?

20 Pfizer products are counterfeited worldwide with Lipitor, Norvasco and Viagra topping the list.

The following is a news report that appeared in the Khaleej Times Online, regarding UAE’s efforts to combat faux pharmaceuticals and was authored by Sajila Saseendran and Emily Meredith (sajila@khaleejtimes.com) 15 February 2009.

The plain white boxes with dull grey lettering that line pharmacy shelves are supposed to contain medicine to improve people’s well being. But worldwide concern over the legitimacy of pharmaceuticals has increased markedly in the last three years. At an open forum attended by representatives of the Ministry of Health and private sector on Thursday in Sharjah, a representative pharmaceutical company Pfizer, said there is still a threat in the Middle East despite recent initiatives to curb illicit trade in fake – and potentially harmful – medicines.

“There are lots of initiatives (being taken) against counterfeiting here. But we cannot say that Middle East region is free of fake medicines, especially because of the presence of many free trade zones here,” Steve Allen, Europe and MENA Senior Director of Global Security for Pfizer, said. “Just a year ago, we had found counterfeited Lipitor in the retail chain here.” The World Health Organisation’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that fake pharmaceuticals – medicines produced by unlicensed manufacturers and introduced directly into the global supply chain –make up one per cent of drug sales in developed countries and approximately 30 per cent in some countries in Asia, Africa and Latin America. A British investigation in January into how the anti-psychotic drug, Zyprexa, entered the national health system highlighted the problem. Some reports suggested that drugs may have found their way into the United Kingdom in shipments that originated in China and passed through UAE ports.

The UAE’s Role: Dubai sits at the nexus of several transit points. Goods from Africa and Asia bound for the rest of the world pass through the city’s ports at a fast pace. This pace – approximately six hours for sea cargo to be checked, driven through Dubai’s roads and put on an outbound plane – appeals to people trying to ship illicit goods, according to Mohammad Al Mari, head of the Intellectual Property Rights Section of Dubai Customs.

“It’s not the location, it’s the infrastructure we have developed,” he said. Al Mari said he liked the pace, especially just a few years ago when the sea to air transfer time was one-third of today’s.” “It used to be fun, but not anymore with the traffic,” Al Mari said, smiling. But the speed is also the reason for his concerns. It has “given people the impression of using an easier, proper supply chain.”

Health and Customs officials in the UAE say they are working to counteract this impression with a set of new initiatives that include a national committee on counterfeit drugs established in January, portable devices for use at entry points to detect drugs and a proposal to increase the number of drug inspectors. The chair of the new national committee and the CEO of Medical Practice and Licence at the Ministry of Health, Dr. Amin Al Amiri, said the committee will extend its reach beyond the pharmaceuticals used to treat chronic conditions like diabetes, hypertension and cardiovascular diseases preferred by counterfeiters to medical devices and food supplements. “It is not just the fake medicines that pose a threat to public health. We need to prevent fake medical devices and food supplements, too,” Al Amiri said. “That is why the committee wants to monitor the import and export of medical devices and food supplements as well.”

The Ministry of Health requires all companies importing prescription, non-prescription and veterinary medicines to obtain a permit and send a copy to the Customs officials. Companies using the UAE’s ports to move these products also have to register. Al Amiri said the Ministry of Health (MoH) last month mandated pre-registration for food supplements and medical devices. “We have stringent procedures for registrations. Manufacturing companies have to produce a lot of certificates,” he said. Customs officials do not typically release medical shipments from port entry points until a trained pharmacist from MoH checks the shipment.

Al Mari said 70-80 per cent of the drugs entering Dubai’s ports are sampled and sent for testing at MoH’s drug control lab in Abu Dhabi. To ensure that the other cargo does not contain illicit imports, Al Mari said Dubai Customs fully offloads and inspects five to seven per cent of all cargo passing through the emirate. Twelve per cent of shipments are scanned. At certain spots, there are tougher regulations. At the dhow site for sea cargo, 100 per cent of all vessels are inspected. Al Amiri said companies have been given a grace period of six months to register their products. From June, shipments with unregistered drugs, devices and supplements will not be allowed entry in the UAE. “As of now, we are releasing the shipment, but we will not allow it go to the market unless the company registers the products within six months. It is for the protection of the community and to have best quality products in the country. We don’t want anything to enter the country unless it is registered and regulated.” The threat at home: Al Amiri said it was difficult to quantify the threat posed by counterfeit pharmaceuticals. “We don’t have a figure for the UAE. But we presume the threat of counterfeiting of mainly the drugs for chronic diseases, such as diabetes and hypertension, because of their wide use, and some other expensive pills,” he said. “We have never detected anything that is very dangerous or lethal. So far, a few of the drugs related to hypertension have been confiscated.” In 2008, Dubai Customs found only one instance of fake product: counterfeit hand cream. Recently, the UAE changed several policies in an effort to protect local residents. If inspectors suspect any item to be fake, it will be immediately reported to the police and sent to the drug inspection section for investigation. Non-registered drugs, once confiscated here, have to be sent back to the country of origin. “We have introduced this new system,” Al Amiri said. “We don’t allow any unwanted drugs to be destroyed here in our land. We don’t want any adverse impact to our environment and public health due to this.”

The UAE has also banned drug repackaging, once done on Emirati soil. “Some companies used to bring some of the non-registered drugs, repack it here and export it to some other countries. When they confiscate these, they think that all those drugs went from here which resulted in negative reputation to the UAE. We have stopped that practice and strictly banned the repackaging of medicines.”

Steve Allen from Pfizer said drug counterfeiting should be punishable more severely than in IPR violations because of the damages they cause. “It is not just about piracy like in the case of counterfeit CDs. Fake medicines can kill people and their trade is an organised crime,” Allen pointed out.

Private investigators employed by big pharmaceutical companies like Pfizer alert regulatory bodies about the entry of fake medicines into the market and any breach in the supply chain. “We would like the Customs to have the same level of focus on counterfeit medicines as on narcotics. Narcotic drug addicts know what they are taking and its potential dangers,” he said. “But it’s innocent patients whose health is affected because of counterfeit prescription drugs. Some can be lethal. We have found rat poison, boric acid and inkjet cartridges in some fake drugs.” About 20 Pfizer products are counterfeited worldwide with Lipitor, Norvasco and Viagra topping the list. Allen said counterfeiters were shifting focus to life-saving from lifestyle medicines because of expected delays in response. Anwar Hussain, assistant manager for purchases and R &D with the Medshop pharmacy chain, presented a paper on health hazards of fake drugs at Thursday’s forum. He called on pharmacists to buy medicines from authorised agents. “Pharmacists should ensure that all products are supplied against valid invoices stating the batch numbers. They should watch out for the products offered at high bonuses or extra discounts by unauthorised suppliers, monitor warnings from manufacturers and look out for pricing labels approved by the MoH.”

Over 120 kgs (265 lbs) of Fake Viagra Bound for America and Europe Seized

One of the largest seizures of Fake Viagra occurred this week in India. A local organization Enforcers of Intellectual Property Rights (EIPR) supplied the police with months of data on the illegal manufacturing and aided the authorities in their investigation.

On 4:00 p.m. Saturday, February 14, 2009 Haryana (India) police raided a supposedly closed manufacturing plant and seized 200 kgs. (440 lbs.) of counterfeit medicine, including 120 kgs. (265 lbs.) of fake Viagra.

The police found evidence that the Viagra drug was being manufactured on site and found the active ingredient of Viagra, sildenafil citrate, in its raw material form as well as packaged products ready for shipping. The spurious drugs were allegedly bound for shipment to the United States, Europe, and Canada.

The Indian police arrested eight people who were working at the company called Chem Pharma Company and are likely to press charges against them and the owner of the company Mr. Bhardwaj.

The investigation is continuing and more raids and arrests are anticipated. A majority of fake erectile dysfunction (ED) medication like Viagra is thought to be produced in India, Pakistan and China. These operations often involve underground criminal organizations which have been linked to terrorist activity around the world.

Due to this recent threat to public health, XStream Systems would caution consumers to buy ED medications only from licensed pharmacists and avoid online purchases from sources other than those supported by actual brick-and-mortar pharmacies. Wholesalers and distributors should verify inventory received. Given the sophistication of this batch of counterfeit drugs molecular authentication methods would be the best countermeasure to block any counterfeit products from entering their business.

Where vs. What

By Charles R. Earl M.A., ABD
CEO, Communication Connections

During my misspent youth, I enjoyed a comic strip called “Spy versus Spy.” Well, this column has nothing to do with that classic confrontation between good and evil. This blog is dedicated to a common-sense comparison of two primary drug safety technologies. The Where versus the What. I have been tangentially involved with the pharmaceutical industry for nearly a quarter century and vividly remember the valiant efforts to get manufacturers to accept RFID as a viable method for enhancing supply-chain safety. Many have embraced the concept, and there is no doubt that providers and patients have reaped huge benefits as a result of the industry’s efforts to enhance safety and reliability.

RFID is a valuable asset in the trend toward better, safer and more effective products for pharmaceutical consumers. The buggy was a vital component of our ancestors’ lives. It allowed for easier movement of goods and families than was available by horseback or walking. In fact, a carriage ride through Central Park is a pleasant (and perhaps romantic) diversion from the hustle-bustle routine of our daily lives. But when it’s time for serious endeavors, we rely on the automobile or the truck. The buggy still works and has some intrinsic value, but when the rubber meets the road, the automobile is critical.

The Where is the primary focus of RFID. Where has the product been (Remember when Mother used to say, “Don’t put that in your mouth. You don’t know where it’s been?”). So, now we know where it’s been, but are we confident that we know what it is? Even when we are absolutely, unequivocally, slam-dunk certain where it’s been, are we willing to put it in our mouths? Do we know what it is?

“Where- versus- What” does not necessarily require that we drown in a pool of angst. Both are important . Knowing the Where is important for underscoring confidence and aiding law enforcement. Knowing the What is vital. People’s and pets’ lives are at stake. RFID is invaluable for integrity in the supply chain. EDXRD is critical for confirming that the product requested is the product received.

Now, let’s change the formula suggested by the title of this column. Where is good. What is good. Where+What versus the bad spy.

Tweet, Tweet, Tweet

Charles R. Earl, MA, ABD
CEO, Communication Connections

Back in the day, deep-shaft miners would lug a caged canary with them to serve as an early warning system if the oxygen supply should fail. If the canary would croak, then miners would hustle out of the hole. Recent events and diligent studies have demonstrated that the “drug safety canary” is developing a weakening “tweet.” The canary is not yet dead, but she is on serious life support.

Remember the concerns surrounding the adulterated heparin last year? My son was in intensive care with heparin as a vital component of his treatment at the very time when instances of the degraded drug were making headlines. An extremely stressful situation was dramatically compounded by the knowledge that a critical element of his care might be compromised. So I, man-on-the-street Charlie Earl, was smacked upside the head by the potential danger of an unsafe pharmaceutical. I was not the one being administered the drug. My son was, but my confidence in the safety of the system and the supply chain was shaken. I wondered “how is it possible for an adulterated product to get to the patient’s beside without having been detected?”

In a January 4th, 2009 article in the UK Guardian, Mark Townsend describes British authorities’ efforts to stem the flood of fake drugs into Britain. He quoted an Interpol official who admitted “to being ‘shocked’ at discovering that fake drugs were more deadly than terrorism.” Even if the representative of the international police agency were exaggerating, the issue of drug counterfeiting is, nonetheless, an enormous and growing problem. Our national level of awareness regarding drug safety is similar to our concerns about identify theft a decade ago. We are aware that a problem exists but believe it to be too small for swift and resolute action. When, however, we become personally affected by the problem (e.g. unwarranted charges on the credit card…or a seriously ill son attached to a multiplicity of machines in a cold and sterile hospital), then our senses are jolted, and we begin to repair our vulnerabilities. Let’s just hope we are not too late.

ZERO IS THE RIGHT NUMBER!

By: Pat Earl, V. P. Business Development, XStream Systems, Inc.

If you had a chance to speak with Katherine Eban, Author of DANGEROUS DOSES, a Rhodes Scholar and a notable speaker these days on the safety of pharmaceuticals in the U.S., I know she would respond “we need to do more because counterfeit, diverted and adulterated drugs are still a real threat to America’s public safety.”

Today, I had the privilege to catch up with Katherine at her home in New York and ask her what her thoughts were on the vulnerabilities of the American drug supply.

Since Katherine released her best seller book in early 2005, the nation’s largest manufacturers and distributors have taken major steps to make the path a pharmaceutical takes from the manufacturer to the patient much safer. The FDA and the State Regulatory Agencies have developed standards for Supply Chain Security that includes identification, tracking, tracing, authentication and validation. As we look today, February 2009, four years have passed since she stunned the pharmaceutical industry and the American public with the chilling reality that criminal counterfeiters and scammers were contaminating the American drug supply. But the story has not ended here.

Globalization of the manufacturing processes has increased the opportunities for drug counterfeiting, drug diversion and other intentional acts that can adversely affect drug quality and safety. I shared with Katherine some of the observations that have stuck with me in my travels to visit some of the largest players in the distribution channel. There appears to be a complacency that pushes the responsibility to ensure that the product is not a fake up the chain.

Wholesalers draft policies to only buy from manufacturers or their sole distributors of record. Large chains and pharmacy benefit managers rely on the contracts that state their suppliers only buy from manufacturers and so on down the line. It’s obvious that there is a very real need for anyone receiving the drugs to be able to validate the path the drug has taken and to verify its authentication. What we are experiencing at all levels is …see no evil, hear no evil, speak no evil – so everything is fine and the problem is fixed.

In the conclusion of Dangerous Doses, Katherine reported that she was asked: “How would you define success when it comes to the problem of counterfeit medicine. What lower-percentage chance of getting such drugs should we be aiming for?” Her answer then was the same as it still is today. “There is only one answer to that question: ZERO.”

There is no such thing as a partial solution to the problem of counterfeit medicine.” Authentication of pharmaceuticals can be accomplished in a quick and easy fashion. Each drug has a unique formulation and therefore a unique molecular structure fingerprint that can be matched against that true standard to validate that the medicine in the package is not a fake, but is, indeed, the real deal.

Does our Drug Supply Chain Have a False Sense of Security?

When it comes to Pharmaceutical Quality -What you see is not always what you get.

It is time for our security measures to move beyond pedigree and taggants that document where our drug supply has been and concentrate on authentication to ensure that the contents are genuine and of standard quality.

As you can see from the recent stories below, pedigrees did nothing to protect consumers from fraudulent and substandard medicines. The sad fact is pedigrees can themselves be counterfeited. Also medicines have become a huge commodity providing those individuals with questionable intentions a lucrative income. Even when false paperwork is finally detected, it can take years to retract the questionable product and bring the criminal to justice.


Thousands 'have taken fake drugs'
Thirty-thousand packs of fake life-saving drugs may have been consumed by NHS patients, the BBC has learned.

Three medicines, Casodex (bicalutamide) for prostate cancer, Plavix (clopidogrel) which treats strokes and heart conditions and Zyprexa (olanzapine) to control schizophrenia, had to be removed from pharmacies and warehouses across the UK in the recall 18 months ago.
http://news.bbc.co.uk/2/hi/health/7865246.stm



How fake drugs got into the NHS
It was the highest state of alert the United Kingdom's medicines watchdog can issue.

A UK wholesaler spotted discrepancies in packaging of stock bought from in Europe.
According to former industry investigator Graham Satchwell reputable companies were duped by sophisticated counterfeits.
http://news.bbc.co.uk/2/hi/health/7865569.stm

Woman faces prison time in drug scheme
A Milford, NH woman has pleaded guilty for her role in a two-year scheme to sell more than $2 million worth of AIDS drugs that were bought from patients around the U.S. and resold under falsified paperwork.
http://www.nashuatelegraph.com/apps/pbcs.dll/article?AID=/20090129/NEWS01/301299836/-1/OPINION02
counterfeit drugs in US

Are Internet Pharmacies Going to Be the Next Domestic Healthcare Crisis?

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

According to information from the FDA (with our thoughts in italics):

• U.S. Consumers buy between $700 and $800 million worth of drugs per year from foreign internet pharmacies.

This is of course is an estimate and most likely a much higher figure. Given the lack of regulation, oversight and total inability to control, this is a conservative estimate at best.

• Packages purchased by U.S. Consumers from foreign internet pharmacies will grow to an estimated 5 million in 2009 from 2 million in 2008.

Again a very high number but consider that these packages will contain multiple products and likely products with a high number of dosages.

• Over 60% of drugs purchased from foreign Internet pharmacies are estimated to be counterfeit, fraudulent or adulterated.

This figure is an increase from 2008 of 10%. These products include non-approved generics, knock offs, semi-effective clones of real drugs with some medication, toxic substances and at best harmless placebos. Bottom line there is a high likelihood that the products bought on-line from a foreign internet site will not be the drug you purchased, totally ineffective and likely harmful to consume.

• U.S. Consumers in 2009 will purchase and consume over 3 million counterfeit, fraudulent or adulterated medications from purchases made through foreign internet pharmacies.

This is conservative number and most likely many millions will be impacted because of the huge quantity of counterfeit product that will be consumed. Three million is just doing the math and considering that only one person will consume part of the fake medication that is coming from overseas. Most likely one package will contain multiple products and many hundreds of dosages that will be consumed by several individuals.

Given these statistics it is somewhat of a given that medications bought through foreign internet pharmacies will have a significant negative impact on healthcare in the United States in 2009. Some will not receive the proper pharmaceutical treatment that they have been prescribed while others may be ingesting toxic substances that will harm their health worsen their condition.

It is also a concern that many of these products will be introduced into the legitimate pharmaceutical supply chain through returns and unscrupulous means.

That is why XStream Systems is continuing its endorsement of consumers only buying products from providers that utilize an authentication technology in their production, distribution and dispensing. Authentication is an important component of validating the quality and efficacy of the drug so that it meets the highest quality and standards that U.S. consumers demand.

To find out more information about XStream Systems and our solutions visit us at www.xstreamsystems.net.

CEO of Hi-Tech Pharmaceuticals sentenced to 4 years for selling Knock-off Drugs

Jared Wheat, the CEO and founder of Hi-Tech Pharmaceuticals was charged $50,000 and sentenced to 50 months in prison for illegally selling prescription drugs online. He distributed fake versions of a variety of medications which included Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which he ultimately sold over the Internet without requiring prescriptions.

Hi-Tech Parmaceuticals is located in Georgia and is known for their herbal supplements which are distributed to a variety of American retailers and convenience stores nationwide. Hi-Tech’s most popular products include Stamina-Rx, which it describes as a "maximum sexual stimulant," Lipodrene, "for advanced appetite control and metabolic stimulation," and Metanabol, a "revolutionary catalyst for increasing lean mass and strength.

By accepting a plea bargain, a variety of other charges against him were dropped. These included such charges as racketeering, blackmail and murder conspiracies, and for spiking supplements with ephedrine alkaloids. The U.S. Food and Drug Administration (FDA) banned ephedrine alkaloid use in 2004 after finding that it has potential for dangerous effects on the heart.

Also as part of the plea, said MSNBC, the defendants admitted to operating a manufacturing facility—described as filthy—in Belize in which they produced generic versions of a variety of medications such as Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which they ultimately sold over the Internet without requiring prescriptions.

Apparently, reported MSNBC, Wheat conspired to murder an FDA agent and to blackmail a former assistant U.S. attorney general. And, while the allegations were made based on information provided by confidential informants, the charge was dropped in plea bargaining talks.

If the leadership of a national known manufacturer who distributes nationwide could instigate distribution of fake products, how can the public be protected?

It is for this reason that pedigree by itself cannot protect consumers– What needs authenticated is not just WHO it was received from but also WHAT was received! – For this reason, we recommend authentication of the product itself. To find out more on how authentication can protect your supply from adulteration – please visit www.xstreamsystems.net.